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Effects of Telemonitoring-supported Game-based Home Exercises in Juvenile Idiopathic Arthritis

Primary Purpose

Exercise Therapy, Juvenile Idiopathic Arthritis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Game-based home exercises
offline asynchronous physiotherapy
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exercise Therapy focused on measuring telemonitoring, physiotherapy, juvenile idiopathic arthritis, game-based exercises, telerehabilitation, remote methods

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Whose are diagnosed with JIA at least 1 year ago Whose are aged 6-16 years Whose are having pain in lower extremity joints for more than the last 6 months Whose have stable medical treatment Whose are at a level to understand the games and perform the activities mentally Exclusion Criteria: Patients with neurological problems in addition to rheumatic diagnosis Individuals who are contraindicated to exercise

Sites / Locations

  • İstanbul University-CerrahpasaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

online synchronous communication application-based telemonitoring group

offline asynchronous physiotherapy application-based telemonitoring group

Arm Description

The telemonitoring-supported program will be conducted with a smartphone application synchronously. The participants will be monitored by the investigators using an online communication application during exercise sessions.

The telemonitoring-supported program will be conducted with a smartphone application. The game-based home exercises will be shared with the participants by a smartphone application. The participants will be monitored by the investigators using a physiotherapy application asynchronously.

Outcomes

Primary Outcome Measures

The Wong-Baker Faces Pain Rating Scale
A self-report tool called The Wong-Baker Faces Pain Rating Scale is used to assess how much pain kids are experiencing. It is widely acknowledged that measuring children's pain is challenging for medical professionals. This is because children express pain differently than adults due to differences in their language, communication, and developmental stages. The Wong-Baker Pain Scale has 6 faces. The first face represents a pain score of 0 and indicates "not hurt". The second face is a 2 represents the pain score and means "it hurts a little". The third face represents a pain score of 4 and "it hurts a little more" shows. The fourth face represents a pain score of 6 and indicates "it hurts more". The fifth face represents a pain score of 8. and shows that "it hurts a lot"; the sixth face represents a pain score of 10 and indicates "worst pain". The unit of this outcome is a score.
Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis Module
Patients with JIA have the Pediatric Quality of Life Inventory (PedsQL) 3.0 arthritis module. This criterion has been translated into Turkish and its validity has been demonstrated. 44 Evaluations are made about pain and suffering (four questions), daily activities (five questions), treatment (seven questions), anxiety (three questions), communication (three questions), and parent and child modules are evaluated separately. The unit of this outcome is a score. Every item is 5-point Likert scale type. Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Higher scores mean better quality of life and fewer problems or symptoms
The Tampa Scale for Kinesiophobia
It is a 17-item scale developed to measure the fear of movement/re-injury. The scale includes parameters of injury/re-injury and fear-avoidance in work-related activities. A 4-point Likert scoring (1 = I strongly disagree, 4 = I totally agree) is used in the scale. After reversing items 4, 8, 12 and 16, a total score is calculated. The person gets a total score between 17-68. A high score on the scale indicates a high level of kinesiophobia. It is recommended to use the total score in studies. In our study, the fear of avoiding movement will be evaluated with TSK. The unit of this outcome is a score.

Secondary Outcome Measures

10 meter walk test
It is widely used and recommended as a measure of gait speed. It can be employed to determine functional mobility, gait. The unit of this outcome is second.
Gait speed
When assessing many aspects of a patient's functional mobility, practitioners find gait speed to be a very useful statistic. Moreover, gait speed is frequently employed as a predictor of general health and function due to its capacity to be altered by a number of body systems. The data will be collected from video recordings that asked participants to walk at a 10-meter walkway and videos will be analyzed with Kinovea 2D movement analysis. The unit of this outcome is meter/second.

Full Information

First Posted
March 29, 2023
Last Updated
October 3, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05837247
Brief Title
Effects of Telemonitoring-supported Game-based Home Exercises in Juvenile Idiopathic Arthritis
Official Title
Effects of Telemonitoring-supported Game-based Home Exercises on Kinesiophobia, Pain and Quality of Life in Juvenile Idiopathic Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 24, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In order to cope with pain, improve quality of life and prevent kinesiophobia in children with juvenile idiopathic arthritis, most of the physiotherapy approaches used so far are standard. However, nowadays, it has been observed that participation in treatment has increased with game-based exercises instead of standard physiotherapy. In addition, remote monitoring applications made it possible to perform physiotherapy programs, which are an integral part of the treatment in children with JIA, who is difficult to reach the clinic due to reasons such school schedule and living area, through remote monitoring. This project aimed to investigate the effects of telemonitoring-supported game-based home exercise programs on pain, kinesiophobia and quality of life. The original aspect of our project is to include telemonitoring-supported game-based home exercise programs as an alternative physiotherapy program in children with JIA. Its contribution to clinical practice is to change the perspective of physiotherapists and children on standard physiotherapy practices, to increase their motivation, and to ensure children's participation in treatment.
Detailed Description
Juvenile rheumatic diseases are chronic diseases with a prognosis ranging from complete recovery to long-term disability. Juvenile idiopathic arthritis (JIA) is the most common rheumatologic disease in children. Pain is one of the main clinical symptoms in JIA. Due to pain, these children with rheumatic diseases avoid moving. The fear of moving because of this pain is defined as kinesiophobia. Kinesiophobia (fear of movement); It is defined as an excessive and unreasonable fear of physical action to avoid harm or re-injury. Its prevalence in chronic pain varies between 50-70%. Regular physical activity and fitness exercises can prevent kinesiophobia; Treatment includes therapeutic exercises and cognitive behavioral therapy. In order to cope with pain, improve quality of life and prevent kinesiophobia in children with juvenile idiopathic arthritis, most of the physiotherapy approaches used so far are standard. However, nowadays, it has been observed that participation in treatment has increased with game-based exercises instead of standard physiotherapy. In addition, remote monitoring applications made it possible to perform physiotherapy programs, which are an integral part of the treatment in children with JIA, who is difficult to reach the clinic due to reasons such school schedule and living area, through remote monitoring. This project aimed to investigate the effects of telemonitoring-supported game-based home exercise programs on pain, kinesiophobia and quality of life. In this study, the participants will be evaluated and training game-based exercises at the baseline examination. Then, the participants will be divided into two groups. Group 1 will be followed the online synchronous communication application-based telemonitoring method and Group 2 will be followed the offline asynchronous physiotherapy application-based telemonitoring method. After the game-based home exercises intervention, the groups will be re-evaluated again and the results will be compared in the groups and between the groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Therapy, Juvenile Idiopathic Arthritis
Keywords
telemonitoring, physiotherapy, juvenile idiopathic arthritis, game-based exercises, telerehabilitation, remote methods

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
online synchronous communication application-based telemonitoring group
Arm Type
Active Comparator
Arm Description
The telemonitoring-supported program will be conducted with a smartphone application synchronously. The participants will be monitored by the investigators using an online communication application during exercise sessions.
Arm Title
offline asynchronous physiotherapy application-based telemonitoring group
Arm Type
Active Comparator
Arm Description
The telemonitoring-supported program will be conducted with a smartphone application. The game-based home exercises will be shared with the participants by a smartphone application. The participants will be monitored by the investigators using a physiotherapy application asynchronously.
Intervention Type
Other
Intervention Name(s)
Game-based home exercises
Intervention Description
online Game-based home exercises are physiotherapy programs that include exercises transformed into game activities to increase the child's participation in the rehabilitation process. The exercises were planned such as; the dwarf camel game as squat exercises; the flamingo balance game as single leg balance exercises and weight-bearing activities etc. The exercise program will be conducted for 6 weeks and 3 sessions in a week.
Intervention Type
Other
Intervention Name(s)
offline asynchronous physiotherapy
Intervention Description
offline asynchronous physiotherapy
Primary Outcome Measure Information:
Title
The Wong-Baker Faces Pain Rating Scale
Description
A self-report tool called The Wong-Baker Faces Pain Rating Scale is used to assess how much pain kids are experiencing. It is widely acknowledged that measuring children's pain is challenging for medical professionals. This is because children express pain differently than adults due to differences in their language, communication, and developmental stages. The Wong-Baker Pain Scale has 6 faces. The first face represents a pain score of 0 and indicates "not hurt". The second face is a 2 represents the pain score and means "it hurts a little". The third face represents a pain score of 4 and "it hurts a little more" shows. The fourth face represents a pain score of 6 and indicates "it hurts more". The fifth face represents a pain score of 8. and shows that "it hurts a lot"; the sixth face represents a pain score of 10 and indicates "worst pain". The unit of this outcome is a score.
Time Frame
immediately After intervention
Title
Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis Module
Description
Patients with JIA have the Pediatric Quality of Life Inventory (PedsQL) 3.0 arthritis module. This criterion has been translated into Turkish and its validity has been demonstrated. 44 Evaluations are made about pain and suffering (four questions), daily activities (five questions), treatment (seven questions), anxiety (three questions), communication (three questions), and parent and child modules are evaluated separately. The unit of this outcome is a score. Every item is 5-point Likert scale type. Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Higher scores mean better quality of life and fewer problems or symptoms
Time Frame
immediately After intervention
Title
The Tampa Scale for Kinesiophobia
Description
It is a 17-item scale developed to measure the fear of movement/re-injury. The scale includes parameters of injury/re-injury and fear-avoidance in work-related activities. A 4-point Likert scoring (1 = I strongly disagree, 4 = I totally agree) is used in the scale. After reversing items 4, 8, 12 and 16, a total score is calculated. The person gets a total score between 17-68. A high score on the scale indicates a high level of kinesiophobia. It is recommended to use the total score in studies. In our study, the fear of avoiding movement will be evaluated with TSK. The unit of this outcome is a score.
Time Frame
immediately After intervention
Secondary Outcome Measure Information:
Title
10 meter walk test
Description
It is widely used and recommended as a measure of gait speed. It can be employed to determine functional mobility, gait. The unit of this outcome is second.
Time Frame
immediately After intervention
Title
Gait speed
Description
When assessing many aspects of a patient's functional mobility, practitioners find gait speed to be a very useful statistic. Moreover, gait speed is frequently employed as a predictor of general health and function due to its capacity to be altered by a number of body systems. The data will be collected from video recordings that asked participants to walk at a 10-meter walkway and videos will be analyzed with Kinovea 2D movement analysis. The unit of this outcome is meter/second.
Time Frame
immediately After intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Whose are diagnosed with JIA at least 1 year ago Whose are aged 6-16 years Whose are having pain in lower extremity joints for more than the last 6 months Whose have stable medical treatment Whose are at a level to understand the games and perform the activities mentally Exclusion Criteria: Patients with neurological problems in addition to rheumatic diagnosis Individuals who are contraindicated to exercise
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gökçe Leblebici, Phd, Pt
Organizational Affiliation
Istanbul Medeniyet University
Official's Role
Study Chair
Facility Information:
Facility Name
İstanbul University-Cerrahpasa
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gökçe Leblebici, Phd, Pt
Phone
05397395718
Email
leblebicigokce@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30031492
Citation
Crayne CB, Beukelman T. Juvenile Idiopathic Arthritis: Oligoarthritis and Polyarthritis. Pediatr Clin North Am. 2018 Aug;65(4):657-674. doi: 10.1016/j.pcl.2018.03.005.
Results Reference
background
PubMed Identifier
30020092
Citation
Arman N, Tarakci E, Tarakci D, Kasapcopur O. Effects of Video Games-Based Task-Oriented Activity Training (Xbox 360 Kinect) on Activity Performance and Participation in Patients With Juvenile Idiopathic Arthritis: A Randomized Clinical Trial. Am J Phys Med Rehabil. 2019 Mar;98(3):174-181. doi: 10.1097/PHM.0000000000001001.
Results Reference
background
PubMed Identifier
18299857
Citation
Minden K, Niewerth M. [Juvenile idiopathic arthritis--clinical subgroups and classification]. Z Rheumatol. 2008 Mar;67(2):100, 102-6, 108-10. doi: 10.1007/s00393-007-0246-5. German.
Results Reference
background
PubMed Identifier
29567379
Citation
Weermeijer JD, Meulders A. Clinimetrics: Tampa Scale for Kinesiophobia. J Physiother. 2018 Apr;64(2):126. doi: 10.1016/j.jphys.2018.01.001. Epub 2018 Mar 19. No abstract available.
Results Reference
background
PubMed Identifier
34425842
Citation
Zaripova LN, Midgley A, Christmas SE, Beresford MW, Baildam EM, Oldershaw RA. Juvenile idiopathic arthritis: from aetiopathogenesis to therapeutic approaches. Pediatr Rheumatol Online J. 2021 Aug 23;19(1):135. doi: 10.1186/s12969-021-00629-8.
Results Reference
background
PubMed Identifier
35409751
Citation
Grassini S. Virtual Reality Assisted Non-Pharmacological Treatments in Chronic Pain Management: A Systematic Review and Quantitative Meta-Analysis. Int J Environ Res Public Health. 2022 Mar 29;19(7):4071. doi: 10.3390/ijerph19074071.
Results Reference
background
PubMed Identifier
35599969
Citation
Hadjiat Y, Marchand S. Virtual Reality and the Mediation of Acute and Chronic Pain in Adult and Pediatric Populations: Research Developments. Front Pain Res (Lausanne). 2022 May 6;3:840921. doi: 10.3389/fpain.2022.840921. eCollection 2022.
Results Reference
background

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Effects of Telemonitoring-supported Game-based Home Exercises in Juvenile Idiopathic Arthritis

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